Prostate CancerNCT02252484
Energy Balance for Prostate Cancer Survivorship
A study testing Weight Loss Program in people with Prostate Cancer, run by Jill Hamilton-Reeves, PhD RD LD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants. Read more about this study
- Who is it for?
- Ages 50 to 72 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Weight Loss Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 72 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
- Body Mass Index (BMI) 25-45 kg/m2
- Have internet access
- Have an iPad/iPhone/iDevice
Who cannot join
- History of 5 alpha reductase inhibitors prior 3 months
- History of radiation therapy
- Taking active cancer treatment
- Undergoing salvage therapy
- Castration-resistant prostate cancer
- Evidence of metastasis
- Evidence of biochemical recurrence
- High risk medical condition (e.g. gout or kidney disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.
Read the detailed description
The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:
- Diet
- Physical activity
- Coaching
- Diet and exercise monitoring tool
The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.
- Conditions
- Prostate Cancer
- Being tested
- Weight Loss Program, Standard of Care
- Keywords
- prostate cancer, prostatectomy, weight loss, prevent weight gain
- Medical subject headings
- Prostatic Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss ProgramOther
Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.
Standard of CareOther
Standard of Care for this patient population.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss intervention Group | Experimental | Participants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience. Receives: Other: Weight Loss Program |
| Comparison Group | Active comparator | All patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight during the post-surgical period
Measured: Change from Surgery to Week 20
Secondary outcomes (4)
Changes in body weight during the pre-surgical weight-loss intervention
Measured: Change from Baseline to Week 8
Changes in diet quality during the pre-surgical weight-loss intervention
Changes will be measured by analyzing results from alternative healthy eating index scores.
Measured: Change from Baseline to Week 8
Prostate cancer status
Evidence of recurrence of cancer
Measured: Week 20
Change in cardiovascular biomarkers
Changes will be measured by analyzing changes in participants lipid panel, c-reactive protein, fasting insulin and fasting glucose.
Measured: Change from Baseline to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jill Hamilton-Reeves, PhD RD LD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Sponsor-investigator, Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center
- Investigators
- Jill Hamilton-Reeves, PhD, RD, LD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252484
- Sponsor's protocol ID
- STUDY00001274
- Status last verified
- Sep 2016
- First submitted
- 18 Sep 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamilton-Reeves JM, Johnson CN, Hand LK, Bechtel MD, Robertson HL, Michel C, Metcalf M, Chalise P, Mahan NJ, Mirza M, Lee EK, Sullivan DK, Klemp JR, Befort CA, Parker WP, Gibbs HD, Demark-Wahnefried W, Thrasher JB. Feasibility of a Weight Management Program Tailored for Overweight Men with Localized Prostate Cancer - A Pilot Study. Nutr Cancer. 2021;73(11-12):2671-2686. doi: 10.1080/01635581.2020.1856890. Epub 2020 Dec 9.
PubMed 33295204
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Balance for Prostate Cancer Survivorship
- ClinicalTrials.gov ID
- NCT02252484
- Acronym / sponsor ID
- STUDY00001274
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostatectomy, weight loss, prevent weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jill Hamilton-Reeves, PhD RD LDUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.
Detailed description
The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:
- Diet
- Physical activity
- Coaching
- Diet and exercise monitoring tool
The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss intervention Group | Experimental | Other: Weight Loss ProgramParticipants will receive tailor weight loss program. Participants will complete 8-weeks of the weight loss intervention prior to having their prostatectomy (weight loss phase). Program includes individual weight coaching, tailored diet and exercise plan, weight coaching and tracking of daily activities. Sessions will be held weekly during the weight loss phase. The groups will be facilitated by a registered dietitian with genitourinary (GU) oncology experience. |
| Comparison Group | Active comparator | Other: Standard of CareAll patients who are unwilling or not ready to engage in a weight loss program will be offered entry into the comparison group arm. |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
- Body Mass Index (BMI) 25-45 kg/m2
- Have internet access
- Have an iPad/iPhone/iDevice
Key exclusion criteria (8 listed)
- History of 5 alpha reductase inhibitors prior 3 months
- History of radiation therapy
- Taking active cancer treatment
- Undergoing salvage therapy
- Castration-resistant prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Loss ProgramProgram has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study. | Other | Weight loss intervention Group |
| Standard of CareStandard of Care for this patient population. | Other | Comparison Group |
Primary outcome
Change in body weight during the post-surgical period
Time frame: Change from Surgery to Week 20
4 secondary outcomes
Changes in body weight during the pre-surgical weight-loss intervention
Time frame: Change from Baseline to Week 8
Changes in diet quality during the pre-surgical weight-loss intervention
Time frame: Change from Baseline to Week 8
Prostate cancer status
Time frame: Week 20
Change in cardiovascular biomarkers
Time frame: Change from Baseline to Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 33295204Hamilton-Reeves JM, Johnson CN, Hand LK, Bechtel MD, Robertson HL, Michel C, Metcalf M, Chalise P, Mahan NJ, Mirza M, Lee EK, Sullivan DK, Klemp JR, Befort CA, Parker WP, Gibbs HD, Demark-Wahnefried W, Thrasher JB. Feasibility of a Weight Management Program Tailored for Overweight Men with Localized Prostate Cancer - A Pilot Study. Nutr Cancer. 2021;73(11-12):2671-2686. doi: 10.1080/01635581.2020.1856890. Epub 2020 Dec 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Hamilton-Reeves, PhD, RD, LD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Program in people with Prostate Cancer, run by Jill Hamilton-Reeves, PhD RD LD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight during the post-surgical period (time frame: Change from Surgery to Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02252484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.